Bloodpressure and NIRS During the Immediate Transition

NCT ID: NCT06168045

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-05-27

Brief Summary

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Blood pressure will be measured in min. 5/10/15 after birth. Cerebral tissue oxygenation (crSO2) monitoring with NIRS in addition to routine arterial oxygen saturation (SpO2) monitoring with pulse oximetry will be performed continuously during the first 15 minutes after birth

Detailed Description

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Conditions

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Blood Pressure Cerebral Tissue Oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Term neonates

Neonates with gestational age 37+0 - 42+0 weeks

Cerebral tissue oxygenation and blood pressure measurement

Intervention Type DIAGNOSTIC_TEST

Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth

Preterm neonates

Neonates with gestational age \< 37+0 weeks

Cerebral tissue oxygenation and blood pressure measurement

Intervention Type DIAGNOSTIC_TEST

Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth

Interventions

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Cerebral tissue oxygenation and blood pressure measurement

Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Term and preterm neonates observed routinely immediately after birth at the resuscitation desk

* Decision to conduct full life support
* Written informed consent

Exclusion Criteria

No decision to conduct full life support

* No written informed consent
* Congenital malformation
Minimum Eligible Age

1 Minute

Maximum Eligible Age

15 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Pichler Gerhard, MD.

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Pichler, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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medical university of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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Pichler G, Cheung PY, Aziz K, Urlesberger B, Schmolzer GM. How to monitor the brain during immediate neonatal transition and resuscitation? A systematic qualitative review of the literature. Neonatology. 2014;105(3):205-10. doi: 10.1159/000357162. Epub 2014 Jan 25.

Reference Type BACKGROUND
PMID: 24481411 (View on PubMed)

Hooper SB, Te Pas AB, Lang J, van Vonderen JJ, Roehr CC, Kluckow M, Gill AW, Wallace EM, Polglase GR. Cardiovascular transition at birth: a physiological sequence. Pediatr Res. 2015 May;77(5):608-14. doi: 10.1038/pr.2015.21. Epub 2015 Feb 4.

Reference Type BACKGROUND
PMID: 25671807 (View on PubMed)

Baik N, Urlesberger B, Schwaberger B, Avian A, Mileder L, Schmolzer GM, Pichler G. Blood Pressure during the Immediate Neonatal Transition: Is the Mean Arterial Blood Pressure Relevant for the Cerebral Regional Oxygenation? Neonatology. 2017;112(2):97-102. doi: 10.1159/000455965. Epub 2017 Apr 21.

Reference Type BACKGROUND
PMID: 28427056 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1026/2022 (34-221 ex 21/22)

Identifier Type: -

Identifier Source: org_study_id

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